United European Gastroenterology Week (UEGW) Virtual 2020 Highlights
Don’t miss our UEGW highlights for a chance to learn more about how biosimilars are changing the treatment landscape for patients with IBD.
The undisputed success of this year’s United European Gastroenterology Week (UEGW) is testament to the UEG community’s impressive dedication to advancing the field of digestive health, even in the face of unprecedented adversity.
For those who treat patients with inflammatory bowel disease (IBD), or are interested in learning more about it, there was plenty of exciting content to choose from. This included a selection of the latest updates in the field of biosimilar research.
Final results of SPOSIB SB2
Among other things, highlights included the much-anticipated final results of SPOSIB SB2, the first prospective study of the infliximab biosimilar, SB2, in patients with IBD. Presented by Dr Fabio Salvatore Macaluso, this study found that the safety and efficacy of SB2 appears to be similar to the infliximab originator and infliximab biosimilar CT-P13. Among the 192 infliximab naïve patients included in the study, 57.3% achieved steroid-free remission, 13.5% achieved a partial response and 29.2% had no response. Interestingly, the rate of steroid free remission was significantly higher in patients who were naïve to both infliximab and anti-TNFs, than those who were infliximab naïve but had previously been exposed to other anti-TNFs (p<0.001). There was also a higher incidence of serious adverse events among those who had previously been exposed to other anti-TNFs. However, importantly, the study concluded that multiple switches were safe1.
Interim results from the French PERFUSE study
Presenting an interim analysis of the ongoing PERFUSE study, Professor Yoram Bouhnik revealed that of the 1374 patients included in the cohort, 744 had IBD. The aim of PERFUSE is to gather real-world evidence on the persistence, effectiveness, and immunogenicity of SB2 in patients transitioning to SB2 from infliximab or a different infliximab biosimilar, as well as in infliximab naïve patients. Professor Bouhnik reported that at 12 months 90% of the transitioned population and 80% of the infliximab naïve population were maintained on SB2. Reassuringly, he also noted that, to date, no concerns regarding the immunogenicity of the drug have emerged2.
Comparing ABP501 with SB5 and adalimumab originator in IBD
Few studies have investigated the use of adalimumab biosimilars in patients with IBD. At this year’s UEGW, Dr Linda Cingolani presented the results of her recent study investigating the effectiveness and tolerability of adalimumab biosimilars ABP501 and SB5 in patients with IBD. This study incorporated retrospective data from 166 patients with moderate-to-severe IBD. Compared to the originator it was concluded that the biosimilars were successful in achieving both clinical remission and steroid-free clinical remission. Dr Cingolani also reported that overall, the biosimilars were well tolerated by patients. This provides reassurance for the continued use of these drugs to treat patients with IBD3.
Switching from adalimumab to a biosimilar
Also addressing the lack of data regarding adalimumab biosimilars in IBD, Dr Martina Sciberras presented the results of her recent research on the clinical safety, efficacy and immunogenicity in patients switching from adalimumab to adalimumab-fkjp. Dr Sciberras reported a comparable clinical efficacy, safety and immunogenicity profile between adalimumab originator and its biosimilar4.
To find out more about how biosimilars are changing the treatment landscape for patients with IBD, and for further information on the safety of efficacy of these drugs, visit our dedicated Learning Zone section “Efficacy and Safety of Biosimilars”.
- Macaluso F. SPOSIB SB2 – A Sicilian prospective observational study of patients with inflammatory bowel disease treated with infliximab biosimilar SB2: Final results. Presented at United European Gastroenterology Week Virtual 2020, 11–13 October 2020. Virtual. P0487.
- Bouhnik Y. PERFUSE: A French perspective/retrospective non-interventional cohort study of infliximab-naïve and transitioned patients receiving infliximab biosimilar SB2; interim analysis. Presented at United European Gastroenterology Week Virtual 2020, 11–13 October 2020. Virtual. P0549.
- Cingolani L. Real-life comparison of adalimumab biosimilar (ABP501) with SB5 and adalimumab originator in inflammatory bowel disease: A multicenter Italian study. Presented at United European Gastroenterology Week Virtual 2020, 11–13 October 2020. Virtual. P0594.
- Sciberras M. Switching from originator adalimumab (Humira®) to biosimilar (Hulio®) in an IBD population. Presented at United European Gastroenterology Week Virtual 2020, 11–13 October 2020. Virtual. P0535.
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